Positioning devices, methods, and systems

ABSTRACT

Embodiments include devices, methods, and systems for positioning devices. An exemplary method comprises: moving a distal end of a tube into a body, the tube including a lumen and a shaft in the lumen, the shaft having a transducer; sending a first signal to the transducer; passing, with the transducer, in response to the first signal, a wave energy into the body; receiving, with the transducer, a reflected portion of the wave energy; generating, with the transducer, a second signal in response to the reflected portion of the wave energy; determining, with a processor, an indicia of the body in response to the second signal; and identifying, with the indicia, a targeted issue in the body; positioning the distal end of the tube at the targeted tissue in response to the indicia; and removing a portion of the targeted tissue with the distal end of the tube.

CROSS-REFERENCE TO RELATED APPLICATIONS

This application claims the benefit of U.S. Provisional Application No.62/370,455, filed Aug. 3, 2016, the disclosure of which is incorporatedherein by reference in its entirety.

TECHNICAL FIELD

Aspects of the present disclosure generally relate to positioningdevices, methods, and procedures. In particular, aspects relate to usingwave energy to position a medical device in a body.

BACKGROUND

Lung cancer is among the leading causes of cancer deaths worldwide, inpart, because most new cases are not presented until later stages ofdevelopment (e.g., at Stage III or IV). Screening for lung cancerreduces mortality by allowing a greater percentage of new cases to bepresented at early stages (e.g., at Stage I or II) where the canceroustissue can be more easily removed. Many screening procedures comprise,for example, identifying tissues that are suspected to be cancerous(e.g., a lung nodule >8 mm), and performing a lung biopsy on theidentified tissue to confirm the presence and/or staging of cancer. Inmany cases, the lung biopsy is performed by placing a biopsy needle intothe lung, and using a series of X-rays to position the biopsy needle atthe identified tissue.

There are many problems with known procedures. For example, multipleX-rays may be required to position the biopsy needle, exposing both thepatient and the physician to high amounts of radiation. This problem isof particular concern to physicians, and their technicians, who mayperform more than one lung biopsy per day, and potentially hundreds peryear. Moreover, because each X-ray captures a still image, and multipleX-rays are required to locate the biopsy needle in three dimensions, thephysician cannot position the biopsy needle in real-time. Numerousstarts and stops are thus required to position the needle, increasingoperating times and the potential of damaging non-targeted tissues.

Aspects of the positioning devices, methods, and systems disclosedherein may solve one or more these problems and/or address other missingaspects of the prior art.

SUMMARY

Aspects of the present disclosure relate to positioning devices,methods, and systems. Numerous aspects are now described.

One aspect of this disclosure is a positioning system. An exemplarysystem may comprise: a tube including a distal end with a tissuepenetrating feature and one or more lumens extending through the tube; ashaft positioned in a first lumen of the one or more lumens; atransducer coupled to the shaft, the transducer being configured togenerate a wave energy in response to a first signal, receive areflected portion of the wave energy, and generate a second signal inresponse to the reflected portion of the wave energy; and one or moreprocessors in communication with the transducer, the one or moreprocessors being configured to generate the first signal, receive thesecond signal, and output indicia of the body in response to the secondsignal. In this system, a wave energy impedance of the tube may besimilar to a wave energy impedance of the shaft, and the indicia mayinclude a location of a targeted tissue in the body.

According to this aspect, the shaft may be movably positioned in thetube. A distal end of the shaft may include a tissue penetratingfeature. The transducer may be mounted on an exterior surface of theshaft, or within an interior of the shaft. In some aspects, thetransducer may include, for example, a cylindrical body extending alonga central longitudinal axis, a proximal end opposite of a distal endalong the central longitudinal axis, an array of side-lookingtransducers on the cylindrical body, an array of forward-lookingtransducers on the distal end, and an array of rearward-lookingtransducers on the proximal end. The array of forward-lookingtransducers may be movably mounted to the distal end of the cylindricalbody. For example, the array of forward-looking transducers may berotatable about the central longitudinal axis of the cylindrical body,as may any other array described herein. A lumen may extend through theshaft and the transducer. The array of side-looking transducers may beconfigured to generate a first wave energy, the array of forward-lookingtransducers may be configured to generate a second wave energy, and thesecond wave energy may be more focused than the first wave energy. Insome aspects, the wave energy may be acoustic energy. For example, thetransducer may include at least one piezoelectric ultrasound transducer,and the first and second signals may be electrical signals.

In other aspects, the indicia may include a graphical representation ofthe body. The one or more processors may be configured to determine, forexample, a condition of the targeted tissue from the indicia. In stillother aspects, the or more lumens may include a second lumen, and thesystem may comprise an elongated tool positioned in the second lumen.For example, the elongated tool may be movably positioned in the secondlumen and include a working end composed of a shape-memory material thatassumes a pre-determined shape when extended distally out of the secondlumen.

Another aspect of this disclosure is a positioning method. An exemplarymethod may comprise: moving a distal end of a tube into a bodypassageway, the tube including a lumen extending therethrough and ashaft positioned in the lumen, the shaft having a transducer; sending afirst signal to the transducer; passing, with the transducer, inresponse to the first signal, a wave energy into the body passagewaythrough the tube and the shaft; receiving, with the transducer, areflected portion of the wave energy; generating, with the transducer, asecond signal in response to the reflected portion of the wave energy;and determining, with a processor, an indicia of the body passageway inresponse to the second signal; identifying, with the indicia, a targetedissue in the body passageway. In some aspects, the method may comprisepositioning the distal end of the tube at the targeted tissue inresponse to the indicia; and removing a portion of the targeted tissuewith the distal end of the tube.

According to this aspect, the indicia may include a graphicalrepresentation of the body, and the method may comprise determining alocation of the targeted tissue with the graphical representation. Themethod may comprise determining a size of the targeted tissue with theindicia. For example, the wave energy may be acoustic energy, and themethod may comprise determining, with the processor, a condition of thetargeted tissue based on the reflected portion of the acoustic energy.In other aspects, the indicia may include a boundary of the targetedtissue, and the method may comprise determining, with the processor,whether the distal end of the tube has penetrated the boundary.

Yet another aspect of this disclosure is another positioning method.This method may comprise: moving a distal end of a tube in a lung, thetube including a lumen extending therethrough and a shaft positioned inthe lumen, the shaft having a transducer mounted therein; sending andreceiving, with the transducer, a wave energy through the tube and theshaft; generating, with a processor, using a reflected portion of thewave energy, indicia of the lung; locating, with the indicia, a lungnodule in the lung; guiding, with the indicia, the distal end of thetube into the lung nodule; and removing a portion of the nodule with thedistal end of the tube.

According to this aspect, the method may comprise guiding, with theindicia, a distal end of the shaft towards the lung nodule. For example,the indicia may include a graphical representation of the lung (or aportion of the lung), and the method may comprise identifying, with oneor more processors, a location of the lung nodule on the graphicalrepresentation. The method may comprise determining, from the indicia, adistance between the distal end of the tube and a proximal surface ofthe lung nodule. The distal end of the shaft may include a tissuepenetrating portion, and the method may comprise: moving the tissuepenetrating portion of the shaft into the lung nodule; and determiningwhether the nodule is solid-filled based upon the reflected portion ofwave energy. In some aspects, the distal end of the tube may include atissue penetrating portion, and the method may comprise: determiningwhether the density of the lung nodule exceeds a pre-determined maximumdensity; and moving the tissue penetrating portion of the tube into thenodule if the pre-determined maximum density is exceeded. In still otheraspects, the shaft may include an echogenic indicator, and the methodmay comprise determining a location of the echogenic indicator with theindicia. For example, the shaft may include a central longitudinal axis,the echogenic indicator may be offset from the central longitudinalaxis, and the method may comprise determining a rotational position ofthe shaft with the indicia based on the location of the indicatorrelative to the central longitudinal axis.

Aspects of a positioning device are also disclosed with reference themethods and systems described above. Numerous exemplary devices,methods, and systems are now described in detail below, each includingaspects relating to the use of wave energy as a means for positioning amedical device in a body (e.g., in a lung) to identify and confirm thelocation of a material in the body (e.g., a tumor in the lung), thematerial having an impedance distinguishable from healthy tissue of thebody (e.g., healthy lung tissue).

It may be understood that both the foregoing summary and the followingdetailed descriptions are exemplary and explanatory only, neither beingrestrictive of the inventions claimed below.

BRIEF DESCRIPTION OF THE DRAWINGS

The accompanying drawings are incorporated in and constitute a part ofthis specification. These drawings illustrate aspects of the presentdisclosure that, together with the written descriptions, serve toexplain the principles of this disclosure.

FIG. 1A depicts a side view of an exemplary device.

FIG. 1B depicts a side view of an element of the device of FIG. 1A.

FIG. 2A depicts a side view of an exemplary system.

FIG. 2B depicts a side view of an element of the system of FIG. 2A.

FIG. 2C depicts a section view of an exemplary device included in thesystem of FIG. 2A taken along a section line 2C-2C illustrated in FIG.2A.

FIG. 3 depicts another exemplary device.

FIG. 4A depicts another exemplary device.

FIG. 4B depicts a side view of an element of the system of FIG. 4A.

FIG. 5 depicts an exemplary method.

DETAILED DESCRIPTION

Aspects of the present disclosure are now described with reference toexemplary positioning devices, methods, and systems. Some aspects aredescribed with reference to a medical procedure (e.g., a lung biopsy),wherein a sensor (e.g., a transducer) is positioned in a body (e.g., ina lung) to identity a targeted tissue in the body (e.g., a solid-filledlung nodule), and guide a needle (e.g., a biopsy needle) toward thetargeted tissue. Any reference to a particular procedure, such as a lungbiopsy; a particular sensor, such as a transducer; a particular body,such as a lung; or a particular instrument, such as a biopsy needle, isprovided for convenience and not intended to limit this disclosureunless claimed. Accordingly, the concepts disclosed herein may be usedwith any analogous device, method, or system—medical or otherwise.

The directional terms “proximal” and “distal,” and their respectiveinitials “P” and “D,” are used to describe relative components andfeatures of the present disclosure. Proximal refers to a position closerto the exterior of the body or a user, whereas distal refers to aposition closer to the interior of the body or further away from theuser. Appending the initials P or D to an element number signifies theelement's proximal or distal location. Unless claimed, these directionalterms and initials are provided for convenience and not intended tolimit the present disclosure to a particular direction or orientation.As used herein, the terms “comprises,” “comprising,” or like variation,are intended to cover a non-exclusive inclusion, such that a device ormethod that comprises a list of elements does not include only thoseelements, but may include other elements not expressly listed orinherent thereto. Unless stated otherwise, the term “exemplary” is usedin the sense of “example” rather than “ideal.”

The relative terms “echogenic” and “anechoic” are used to describecharacteristics of certain “materials” in the present disclosure. Theterm materials may include any organic or non-organic material,including body fluids and tissues. The term echogenic may be attributedto materials with a higher resistance or impedance to a wave energy(also referred to as wave energy impedance), meaning that at least aportion of the wave energy will be reflected off such materials. Forexample, an echogenic material may produce internal echoes, such asreflections of ultrasound waves. Air and metal, for example, may beconsidered echogenic materials in some ultrasound applications. The termechogenic may also be used to describe a relative difference between twomaterials. For example, an internal echo may be produced by a firstmaterial (e.g., air) and a second material (e.g., metal) in response towave energy. If a magnitude of each echo is different, then thosematerials may be described as echogenic with respect to one another.Conversely, the term anechoic may be attributed to materials with alower resistance or impedance to wave energy (or low wave energyimpedance), meaning that at least a portion of the wave energy will passthrough such materials. Healthy lung tissue and certain polymers, forexample, may be considered anechoic materials in some ultrasoundapplications. The term anechoic may also be used to described a relativesimilarity between two materials. For example, if the magnitude of anecho produced by a first material (e.g., lung tissue) is equal to amagnitude produced by a second material (e.g., a polymer), then thosematerials may be described as being anechoic with respect to oneanother. Unless claimed as such, neither of these relative terms,echogenic or anechoic, is intended to be absolute.

The term “indicia” is used in this disclosure to mean any real-timeindication of a particular characteristic of a body. One form of indiciais a data model that is generated in response to one or more electricalsignals and usable to determine characteristics of the body, such as thelocation and/or size of a cavity in the body, the location of itsboundaries, and the location of a targeted tissue in the cavity. Thedata model may, for example, be created by an operator or processor, andused by the operator as a real-time guide to position a medical devicein the body. Another form of indicia is a two- or three-dimensionalgraphical representation of the body that is generated in response tothe one or more electrical signals, or with the data model. Thegraphical representation may also be used by the operator as a real-timeguide to position a medical device in the body.

One aspect of the present disclosure is an exemplary device 10configured to generate indicia of a body. As shown in FIG. 1A, device 10may comprise a tube 20 with a lumen 22 extending therethrough, a shaft40 in lumen 22, and a transducer 50 in shaft 40. Transducer 50 maygenerate a wave energy (e.g., acoustic energy, laser energy, vibratoryenergy, or the like) that is passed into the body through tube 20, shaft40, and/or a fluid (e.g., saline). According to this disclosure, areflected portion of the wave energy is returned to transducer 50 fromthe interior surfaces of the body. Transducer 50 of FIGS. 1A-B generatesan electric signal in response to the reflected portion of the waveenergy. This electric signal may, in turn, be used to generate indiciaof the body.

Tube 20 of FIG. 1A is an elongated element that extends along a centrallongitudinal axis X-X from a distal end 20D. A lumen 22 extends throughtube 20 in a direction parallel to axis X-X, although tube 20 mayinclude any number of lumens 22 extending therethrough. The distal end20D of tube 20 of FIG. 1A has a penetrating feature 24 configured topenetrate the surfaces of the body. For example, penetrating feature 24may be an edge of distal end 20D that has been sharpened to remove aportion of tissue from a body when distal end 20D is positioned at thetissue and moved in a linear and/or rotational direction relativethereto. The structure and uses for penetrating feature 24 may includeany cutting and/or piercing implementations associated with biopsyneedles, including blades, sharpened points, and the like.

Shaft 40 is an elongated element that extends in a direction parallel toaxis X-X. In FIG. 1A, shaft 40 is movably positioned in lumen 22. Shaft40 may be positioned for translational movement (i.e., movement in aproximal-distal direction along axis X-X) and/or rotational movement(i.e., movement about axis X-X). A distal end 40D of shaft 40 of FIG. 1Aincludes a penetrating feature 44 configured to penetrate the interiorsurfaces of the body. Penetrating feature 44 of FIG. 1 includes a distalpoint that is formed on distal end 40D and configured to penetratetissue when moved out of lumen 22 in a direction parallel to axis X-X.Any aspect of penetrating feature 24 of tube 20 may be used withpenetrating feature 44 of shaft 40.

Transducer 50 of FIG. 1A may be mounted on, mounted in, or otherwisecoupled to shaft 40 at, for example, a location adjacent distal end 40D.As shown, transducer 50 may include any means for generating andreceiving wave energy. For example, transducer 50 may be configured to:generate one or more wave energies in response to a first electricalsignal; receive a reflected portion of the wave energies (if present);and generate a second electrical signal in response thereto. Exemplarywave energies may include acoustic energy, laser energy, and the like,such as those energies typically used for ultrasound, lidar, radar,sonar, and the like. The first and second electrical signals may bemodified (e.g., pulsed) according to any existing method so as tomaximize the capability of a particular wave energy.

In one aspect, the wave energy is acoustic energy, and transducer 50includes at least one array (e.g., a two- or three-dimensional array) ofpiezoelectric ultrasound transducers configured to generate anultrasonic wave (e.g., a pulse or train of pulses) in response to thefirst electrical signal, and generate the second electrical signal inresponse to a reflected portion of the ultrasonic wave. A frequency ofthe ultrasound wave may be selected based upon a desired combination ofaccuracy and depth. For example, if greater accuracy is desired, then ahigher frequency may be used; whereas, if greater depth is required,then a lower frequency may be used. In some aspects, the frequency maybe approximately 5 MHz or lower; between approximately 5 and 20 MHz;between approximately 10 and 30 MHz; at least 40 MHz; approximatelybetween 20 and 60 MHz; or approximately 60 MHz or lower. Any suitableintermediate and/or comparable frequency values and/or ranges may beused. In some aspects, a plurality of transducers 50 may used, wherein,responsive to one or more signals, a first portion is configured tooptimize accuracy and a second portion is configured to optimize depth.

An exemplary transducer 50 is illustrated in FIG. 1B as having acylindrical body 52 with a distal end 52D opposite of a proximal end52P. As shown, an array of forward transducers 53 is mounted on distalend 52D, while an array of side-looking transducers 54 are mounted onbody 52, and an array of rearward-looking transducers 55 is mounted onproximal end 52P. Each array 53, 54, and 55 may include a plurality oftransducers that, individually or in combination, generate the waveenergy in response to the first electrical signal, and generate thesecond electrical signal in response to the reflected portion of thewave energy. Each second electrical signal may be used to generateindicia of the body. Arrays 53, 54, and 55 also may be arranged toenhance the indicia. For example, locating forward (53), side (54) andrearward (55) arrays on opposing proximal and distal ends 52P and 52D ofbody 52 may provide for an accurate, three-dimensional representation ofthe body no matter the proximal-distal location of transducer 50relative to tube 20, shaft 40, and/or an interior surface of the body.Although a cylindrical transducer with forward, side, andrearward-looking transducers is shown in FIG. 1B, other suitable shapesand configurations may be used.

Numerous types of indicia may be generated with device 10. For example,the second electrical signal from transducer 50 may be used to generateindicia including geometric data concerning the body, such as the size,shape, and orientation of a cavity in the body. In other aspects, theindicia may further include targeting data concerning the identificationand location of a targeted tissue in the body relative to said geometricdata. For example, different tissues in the body (e.g., healthy lung orliver tissue versus cancerous lung or liver tissue) may have differentwave energy impedances. These differences may be determined from thesecond electrical signals and used to generate indicia including, in oneaspect, a graphical representation of the body that distinguishesbetween the targeted tissues and other, non-targeted tissues. Usingsimilar comparative methods, the indicia may likewise be used todetermine, for example, the relative sizes of each targeted tissue, thedensity and/or porosity of said tissues, the relative locations of aplurality of said tissues, optimized paths thereto and therebetween, andthe like.

Another aspect of the present disclosure is now described with referenceto a system 100 including a device 110 that, like device 10, may be usedto generate indicia of a body, depicted as a lung 1 in FIG. 2A. In oneaspect, system 100 is used to perform a biopsy on a lung nodule 3 inlung 1. System 100 includes a device 110 that is similar to device 10,but within the 100 series of numbers. For example, device 110 of FIG.2A, similar to device 10 of FIG. 1A, includes a tube 120 with a lumen122, a shaft 140 in lumen 122, and a transducer 150 mounted on, in, orotherwise coupled to shaft 140. Like reference numbers are used todescribe like elements of devices 10 and 110 wherever possible. System100 further includes a processor 160 in communication with transducer150.

Tube 120 of FIG. 2A has a distal end 120D, a distal end portion 121, anda proximal end portion 123 arranged linearly along a centrallongitudinal axis X-X. Distal end 120D has a penetrating feature 124similar to penetrating feature 24 described above. A lumen 122 extendsthrough end portions 121 and 123 of tube 120 along axis X-X. At leastthe distal end portion 121 may be composed of an anechoic materialhaving a wave energy impedance similar to that of a body tissue and/or afluid. According to one aspect of system 100, the anechoic material is abiocompatible and/or polymeric material (e.g., a polyetheretherketone orPEEK) having an acoustic impedance similar to that of the body tissueand/or fluid. These acoustic impedances be approximately equal, orwithin a range of approximately 10% to 20% of each other. For example,the polymeric material may have an acoustic impedance proximate to thatof a healthy tissue (e.g., a lung tissue having an acoustic impedance ofabout 1.8×10⁵ kg/(M²*s)) and/or biocompatible fluid (e.g., a water-basedsolution having an acoustic impedance of about 1.52×10⁶ kg/(M²*s).

Shaft 140 is movably positioned in lumen 122. A section view of tube 120and shaft 140 is shown in FIG. 2C. As shown, for example, an exteriordiameter of shaft 140 is offset from an interior diameter of lumen 122to define an annular channel 126. Shaft 140 may be composed of ananechoic material having a wave energy impedance similar to that of thedistal end 121 of tube 120 and/or the aforementioned fluid. For example,shaft 140 may be composed of a PEEK tuned to match a body tissue and/ora saline. According to this aspect, the wave energy impedance of tube120, shaft 140, and the fluid may render any of those elements fully orpartially anechoic. For example, the impedance of tube 120 and shaft 140may be tuned to match the impedance of a body tissue when exposed to aspecific type of wave energy. In some aspects, a proximal end portiontube 120 may be composed of the same anechoic material as distal endportion 121 of tube 120.

Tube 120 and shaft 140 may include one or more echogenic markers. Forexample, as shown in FIG. 2A, a first echogenic marker 125 may separatethe distal and proximal end portions 121 and 123 of shaft 120. Firstmarker 125 is depicted as a metallic annulus mounted between endportions 121 and 123. A second echogenic marker 145 may be included onshaft 140. For example, as shown in FIGS. 2B-C, second echogenic marker145 is depicted as one or more metallic strips mounted on shaft 140.These first and second markers 125 and 145 may, for example, be usedindividually or in combination to determine the disposition of shaft 140relative to tube 120. For example, because markers 125 and 145 are madeof an echogenic material (e.g., a metal), they may be highlighted on agraphical representation generated from the indicia so that a physicianmay move (e.g., rotate or steer) shaft 140 by a precise amount (e.g., anincremental distance or angle) relative to tube 120, in real-time, bycomparing the relative positions of markers 125 and 145.

An exemplary transducer 150 is depicted in FIGS. 2A-C. As shown in FIG.2B, transducer 150, like transducer 50, may have a cylindrical body witha distal end 152D opposite of a proximal end 152P. A section view ofshaft 140 and transducer 150 is depicted in FIG. 2C. Shaft 140 andtransducer 150 of FIG. 2C cooperate to define a shaft lumen 146extending through shaft 140 in a direction parallel to axis X-X. Similarto above, an array of forward-looking transducers 153 is mounted ondistal end 152D, while an array of side-looking transducers 154 ismounted on body 152, and array of rearward-looking transducers 155 ismounted on proximal end 152P. Transducer 150 may be configured to matchthe capabilities of transducer 50. For example, as above, each array153, 154, and 155 may be configured to generate a wave energy uponapplication of a first electrical signal, and generate a secondelectrical signal upon receiving a reflected portion of the wave energy.

The wave energy impedance of tube 120 and shaft 140 may determine thelocation of transducer 150. For example, if tube 120 and shaft 140 aremade of similar anechoic materials (e.g., PEEK), then the distal endportion 121 of tube 120 may be used to pierce a body tissue, meaningthat transducer 150 may be located anywhere on or within shaft 140and/or tube 120 because a majority of the wave energy will pass througheach element. Alternatively, if distal end portion 121 of tube 120 ismade of an echogenic material (e.g., stainless steel), then transducer150 should be located on a portion of shaft 140 that is extendable fromtube 120 to expose transducer 150, else a majority of the wave energywill not escape tube 120.

In system 100, the capabilities of transducer 150 may be modified byshaft lumen 146 to permit addition of new arrays, sensors, tools, andthe like. In some aspects, at least forward-looking array 153 of FIG. 2Bmay include, for example, a toroidal transducer configured to generate awave energy that is more intense and/or focused in a direction parallelto axis X-X, thereby improving the quality of indicia generated withsystem 100. In some aspects, the array of side-looking transducers 154may be configured to generate a first wave energy, the array offorward-looking transducers 155 may be configured to generate a secondwave energy, and the second wave energy is more focused than the firstwave energy, thereby improving the quality of the indicia along axisX-X. Additional arrays may be added to the interior surfaces of lumen146 for like effect.

A sensor may be provided in lumen 146. For example, a sensor may beplaced on an interior surface of lumen 146 to track the location ofshaft 140 (or marker 145) relative to tube 120 (or marker 125) as itpasses by said sensor along axis X-X. Other elongated elements, such asa guide wire, an optical cable, or an elongated tool, may be deliveredto lung 1 through shaft lumen 146.

A portion of transducer 150 may be movably mounted in lumen 146. Forexample, as shown in FIG. 3 , forward-looking array 153 of transducer150 may be a rotational planar transducer that is movably mounted on adistal surface 192 of a platform 190. An actuator 194 may extendproximally from platform 190 for receipt in lumen 146. Actuator 194 maybe operable in lumen 146 to move platform 190. For example, actuator 194may include a motor that is operable with the interior surfaces of lumen146 to move platform 190, or a portion that extends through lumen 146for manual operation by application of force to a proximal end ofactuator 194. In either instance, forward-looking array 153 is rotatableabout axis X-X to modify the indicia. Similar modifications may be madeto side-looking array 154 and/or rearward-looking array 155 withoutdeparting from this disclosure. For example, each array 153, 154, and155 may be independently rotatable about axis X-X.

Processor 160 is in communication with transducer 150 and may includeone or more processors that are local (e.g., an element of device 10)and/or remote (e.g., an internet connected server) thereto. Any wired orwireless means may be used to facilitate communication between processor160 and transducer 150. In FIG. 2A, for example, a set of conductors 162extend between transducer 150 and processor 160. Conductors 162 mayinclude, for example, at least one conductor 162 extending betweenprocessor 160 and each array 153, 154, and 155 to deliver the firstelectrical signal from processor 160 to array 153-155; and deliver thesecond electrical signal from arrays 153-155 to processor 160.

Processor 160 outputs indicia of lung 1 in response to the secondelectrical signals. For example, as illustrated in FIG. 2A, the waveenergy may be an acoustic energy 7, and lung 1 may include a pluralityof air-filled lung nodules 2 and a plurality of solid-filled lungnodules 3. Because the acoustic impedance of each air-filled nodule 2may be lower than the acoustic impedance of each solid-filled nodule 3,the magnitude of acoustic energy reflected from an air-filled nodule 2may be less than the magnitude of acoustic energy reflected from asolid-filled nodule 3. These magnitude difference are reflected in thesecond electrical signals, which may then be analyzed by processor 160to output the indicia. To continue the previous example, processor 160may use the magnitude of each second electrical signal to generate agraphical representation of lung 1, and the respective differencesbetween each magnitude to locate one or more solid-filled lung nodules 3on the graphical representation. An operator may, thus, use therepresentation as a real-time guide to position distal end 120D ofdevice 110 at one of the solid-filled nodules 3.

Using other comparative methods, processor 160 may likewise be used todetermine, for example, the size of a particular solid-filled nodule 3,the location of a plurality of nodules 3 in lung 1, a condition (e.g.,the density) of a particular nodule 3, and the like. Still othercapabilities may be realized with system 100. For example, because eachof tube 120, shaft 140, and the fluid have as similar wave energyimpedance, transducer 150 may be “always-on” because the indicia outputby processor 160 is not affected by the position of shaft 140 relativeto tube 120. In this regard, there is no need to position the distal end140D of shaft 140 at a point distal of the distal end 120D of tube 120,as shown in FIG. 2A. As a further example, because of shaft lumen 146,processor 160 may be in communication with another element extendingthrough lumen 146, such as a laser source coupled to an optical fiberthat extends through lumen 146 to direct a wave energy (i.e., laserenergy) towards one of the solid-filled nodules 3.

Still other aspects of the present disclosure are described withreference to a device 210. As shown in FIG. 4A, device 210, like devices10 (FIG. 1A) and 110 (FIG. 2A), may be used to generate indicia of abody. Like element numbers are used to describe like components ofdevice 210 wherever possible, but within the 200 series of numbers. Forexample, device 210 of FIG. 4A, similar to device 10 of FIG. 1A,includes a tube 220 with a first lumen 222A, a shaft 240 in first lumen222A, and a transducer 250 in or on shaft 240. In contrast to above,tube 220 includes a second lumen 222B, and an elongated tool 280 insecond lumen 222B.

For tube 220, first lumen 222A extends through tube 220 along first axisX₁-X₁, while second lumen 222B extends through tube 220 along a secondlongitudinal axis X₂-X₂ that is parallel to first longitudinal axisX₁-X₁. A section view of tube 220 is provided in FIG. 4B. As shown,lumen 222A and axis X₁-X₁ are offset from lumen 222B and axis X₂-X₂along a lateral axis Y-Y. Shaft 240 is movable in first lumen 222Arelative to axis X₁-X₁, like shafts 40 and 140 described above.Transducer 250 is mounted in, on, or otherwise coupled to shaft 240 ofFIG. 4A and configured to generate wave energy and responsive electricalsignals like those described for transducers 50 and 150. At least adistal end portion 221 of tube 220 and/or shaft 240 may be composed ofan anechoic material with a wave energy impedance similar to a fluid,such as saline. As shown in FIG. 4A, the distal end 220D of tube 220 hasa penetrating feature 224.

Elongated tool 280 is movable in second lumen 222B relative to axisX₂-X₂ in a translational and rotational manner. For example, the distalend 220D of tube 220 may be placed adjacent tissue (e.g., tissue 3 ofFIG. 2A) so that a distal end 280D of tool 280 may be moved distally toengage the tissue. Tool 280 of FIG. 4A has a working end 284 configuredto perform a procedure on the tissue. In one aspect, working end 284 iscomposed of a shape-memory metal that forms a pre-determined shape whenend 284 is extended distally from, and thus unrestrained by, lumen 222B.The pre-determined shape of end 284 illustrated in FIG. 4A may positiona tip 286 of working end 284 adjacent a tissue along an axis transverseto axis X₁-X₁ and/or X₂-X₂.

All or at least portions of elongated tool 280 may have a wave energyimpedance similar to that of tube 220, shaft 240, and/or the fluid,allowing the wave energy to pass through each of those elements. Ifcomposed of a metal, then working end 284 may have a different waveenergy impedance so that the position of tip 286 may be determined fromthe indicia. For example, in a graphical representation generated fromthe indicia, using the wave energy, working end 284 and tip 286 may bedistinguishable from the body, a targeted tissue in the body, and theremainder of device 210, each of which may have a wave energy impedancedifferent from that of tip 286.

Various echogenic markers may be provided on tube 220, shaft 240, and/ortool 280 so that the relative locations of these elements may bedetermined from the indicia. FIG. 4A, for example, shows a tube 220 witha first echogenic marker 225 separating the distal end portion 221 oftube 220 from the remainder of tube 220. In one aspect, first marker 225is a metal annulus. Shaft 240 of FIG. 4A includes a plurality of secondechogenic markers 227A-C extending along a length thereof. Either ofmarkers 227A-C and 287A-C may be a plurality of metal strips spacedapart longitudinally on shaft 240 or tool 280 at regular intervals.Accordingly, the indicia may be used to determine a distance betweendistal end 220D of tube 220 and transducer 250 by comparing the distancebetween marker 225 and one of markers 227A-C. An operator may, forexample, use the indicia to determine an extension depth for shaft 240by comparing, in real-time, the distance between first marker 225 andone or more of the second markers 227A-C.

The operator may also use the indicia to determine a distance betweendistal end 220D of tube 220 and portions of tool 280. As shown in FIG.4A, for example, tool 280 may include a plurality of third echogenicmarkers 287A-C extending along a length thereof. An operator may, thus,use the indicia to determine an extension depth for tool 280 bycomparing, in real-time, the distance between first marker 225 and oneor more of third markers 287A-C. In some aspects, the distance betweenmarker 225 and one of markers 287A-C of FIG. 4A may be used to determinewhether working end 284 has been extended from second lumen 222B and/orassumed its pre-determined shape. For example, a first distance betweenthe distal-most marker 287A and the intermediate marker 287B may be usedto determine whether tip 286 has been extended out of second lumen 222B,while a second distance between intermediate marker 287B and theproximal-most marker 287C may be used to determine whether working end284 has assumed its pre-determined shape. In some aspects, thepre-determined shape of working end 284 may be configured so that each(e.g., incremental) movement of tool 280 along axis X₂-X₂ moves tip 286by a corresponding (e.g., incremental) amount in a direction transverseto axis X₂-X₂.

Other aspects of the present disclosure include exemplary methods ofusing devices 10, 110, and 210. An exemplary method 300 is shown in FIG.4 and now described with reference to device 10 of FIGS. 1A-B. Theillustrated method comprises: preparing device 10, which includes tube20, shaft 40, and transducer 50 (310); moving distal end 20D of tube 20into an body (320); sending a first electrical signal to transducer 50(330); passing a wave energy into the body with transducer 50 inresponse to the first electrical signal (340); receiving a reflectedportion of the wave energy with transducer 50 (350); generating a secondelectrical signal in response to the reflected portion of the waveenergy (360); and determining indicia of the body with the first andsecond electrical signals (370). Method 300 may optionally includepositioning, for example, the distal end 20D of the tube 20 in the bodyin response to the indicia (380).

Preparing device 10 (310) may include any methods necessary to generatethe indicia, such as sterilization, providing power, enablingcommunications, and the like. Moving distal end 20D (320) may likewiseinclude any methods necessary to access the body, including invasive andnon-invasive surgical methods, and/or methods of imaging guidance.Sending the first electrical signal to transducer 50 (330) may beperformed by a processor, such as processor 160 of FIG. 2A. A waveenergy may then be generated by transducer 50 and passed into the bodyin response to the first electrical signal (340). For example, asdescribed above, transducer 50 may be a piezoelectric actuator thatgenerates an acoustic wave energy by oscillating in response to thefirst electrical signal. A reflected portion of the wave energy may bereturned to transducer 50 from the interior surfaces of the body. Thus,method 300 at 350 further includes receiving a reflected portion of waveenergy with transducer 50.

The wave energy may be sent and received through portions of tube 20 andshaft 40. To enhance the indicia, each of tube 20 and shaft 40 may havea similar wave energy impedance so that the wave energy may be passedthrough tube 20 and shaft 40 without distortion. For example, movingdistal end 20D of tube 20 into a body (320) may further comprise movingshaft 40 relative to tube 20 until distal end 20D of tube 20 is distalof distal end 40D of shaft 40. Because tube 20 and shaft 40 share acommon wave energy impedance, the quality of any indicia generated fromthe second electrical signal may be similar no matter the position ofdistal ends 20D and 40D.

Generating a second electrical signal in response to the reflectedportion of the wave energy (360) may be performed by transducer 50. Iftransducer 50 includes arrays 53, 54, and 55, as described above, andeach array 53, 54, and 55 generates a plurality of second electricalsignals, then generating the second electrical signal (360) may furthercomprise combining the plurality of second signals. Determining anindicia of the body with the first and second signals (370) may beperformed by a processor that, as described above, analyzes the firstand second signals, performs various calculations therewith, and outputsthe indicia. These determinations (370) may further include determininga magnitude and/or timing of each second electrical signal, comparingthe magnitudes and/or timing of each second signal, and identifying atargeted tissue in the body based upon such comparisons. Similarcomparative methods be used to determine, for example, the size of thetargeted tissue, the location of a plurality of such tissues, acondition of said tissues (e.g., density or porosity), and the like.Aspects of the wave energy may be varied to support thesedeterminations. For example, method 300 may further include identifyingthe boundaries of the body with a first wave energy generated bytransducer 50, and identifying a targeted tissue in the body with asecond wave energy generated by transducer 50.

Although not required, method 300 of FIG. 4 may further includepositioning distal end 20D of the tube 20 adjacent a targeted tissue inthe body (e.g., healthy lung tissue and/or a lung tumor) in response tothe indicia (380). Distal end 40D of shaft 40 may be similarlypositioned. In some aspects, distal end 20D is positioned by a machinein response to indicia including a data model; while in other aspects,distal end 20D is positioned by a human in response to indicia includinga graphical representation of the body. Distal ends 20D and/or 40D maybe positioned at the targeted tissue in this manner. Method 300 mayfurther comprise: confirming that distal end 20D, for example, ispositioned at the targeted tissue, and performing a procedure on thetargeted tissue. An exemplary procedure may, for example, includingremoving shaft 40 from lumen 22, and performing an aspiration biopsy onthe targeted tissue.

Aspects of method 300 may be modified for use with system 100. Forexample, each of tube 120 and shaft 140 may have a similar wave energyimpedance to the fluid so that the wave energy may be passed throughtube 120, shaft 140, and/or the fluid without distortion. In otheraspects of method 300, the first electrical signal may be sent byprocessor 160 at 330, the second electrical signal may be received atprocessor 160 at 360, and processor 160 may be used to determine theindicia at 370. Because of processor 160, any number of additionaldetermination steps may be included in method 300, including thosedescribed herein. Echogenic markers 125 and 145 of system 100 (FIGS. 2Aand C) may also be used with method 300. For example, method 300 at 370and 380 may comprise determining indicia including a distance betweendistal end 120D of tube 120 and a solid-filled lung nodule 3, and movingfirst echogenic marker 125 on tube 120 relative to second echogenicmarker 145 on shaft 140 by an amount equal to said distance. In otheraspects, method 300 may further include removing shaft 140 from tube120, and either removing fluid from lung 1, or performing an aspirationbiopsy on solid-filled lung nodule 3.

Still other aspects of method 300 may be modified for use with device220. For example, positioning the distal end 220D of tube 220 (380) mayfurther include positioning the distal end 280D of tool 280 at thetargeted tissue. The indicia determined at 370 of method 300 may be usedto guide working end 284 of tool 280. For example, method 300 mayfurther comprise determining a distance between tip 286 and a targetedtissue, and moving tube 220 and/or tool 280 to ensure that tip 286 willbe moved toward the targeted tissue when working end 284 forms itspre-determined shape. Additional echogenic markers may be placed on tube220 and/or tool 280 to facilitate such movements.

The various aspects of method 300 may be performed in any order.Moreover, in some aspects, method 300 may comprise less than all of thedescribed aspects without departing from this disclosure. For example,the aspects of method 300 at 310 and/or 380 of FIG. 4 may be omitted.Method 300 also may be modified to accommodate the various capabilitiesand structures of devices 10, 110, and/or 210 described herein, eachpossible variation being part of this disclosure.

While principles of the present disclosure are disclosed herein withreference to illustrative aspects for particular applications, thedisclosure is not limited thereto. Those having ordinary skill in theart and access to the teachings provided herein will recognizeadditional modifications, applications, aspects, and substitution ofequivalents all fall in the scope of the aspects disclosed herein.Accordingly, the present disclosure is not to be considered as limitedby the foregoing description.

The invention claimed is:
 1. A system for obtaining a tissue biopsy froma body, the system comprising: a tube including a distal end with afirst tissue penetrating feature and one or more lumens extendingthrough the tube; a shaft movably positioned in a first lumen of the oneor more lumens extending through the tube, wherein a distal end of theshaft includes a second tissue penetrating feature configured topenetrate tissue while extended out of the first lumen; a transducercoupled to the shaft, the transducer being configured to generate a waveenergy in response to a first transmission signal, receive a pluralityof reflected portions of the wave energy, wherein each of the pluralityof reflected portions of the wave energy have a corresponding magnitudevalue, generate a plurality of second signals including a first signalbased on the corresponding magnitude value of a first reflected portionof the plurality of reflected portions of the wave energy, receive asecond reflected portion of the plurality of portions of the waveenergy, and generate the plurality of second signals including a secondsignal based on the corresponding magnitude value of the secondreflected portion of the wave energy; and one or more processors incommunication with the transducer, the one or more processors beingconfigured to: generate the first transmission signal, receive theplurality of second signals including the first signal and the secondsignal, wherein the first signal includes the corresponding magnitudevalue of the first reflected portion of the plurality of reflectedportions of the wave energy and the second signal includes thecorresponding magnitude value of the second reflected portion of theplurality of reflected portions of the wave energy, analyze thecorresponding magnitude value of the first reflected portion of theplurality of reflected portions of the wave energy with thecorresponding magnitude value of the second reflected portion of theplurality of reflected portions of the wave energy, determine therespective difference of each magnitude value to identify a first lungnodule corresponding to the first signal of plurality of second signalsand to identify a second lung nodule corresponding to the second signalof the plurality of second signals, and output indicia of the first lungnodule as targeted tissue and the second lung nodule as non-targetedtissue.
 2. The system of claim 1, wherein the transducer is locatedwithin an interior of the shaft.
 3. The system of claim 2, wherein thetransducer includes an array of side-looking transducers, an array offorward-looking transducers, and an array of rearward-lookingtransducers.
 4. The system of claim 3, wherein the array offorward-looking transducers is movable relative to the shaft.
 5. Thesystem of claim 1, wherein the transducer includes at least onepiezoelectric ultrasound transducer, and the first and second signalsare electrical signals.
 6. The system of claim 1, wherein the indiciaincludes a graphical representation of the body.
 7. The system of claim1, wherein the transducer includes one or more of an array ofside-looking transducers, an array of forward-looking transducers, andan array of rearward-looking transducers.
 8. The system of claim 1,wherein a processor of the one or more processors is configured todetermine a condition of the targeted tissue based on the reflectedportion of the wave energy.
 9. The system of claim 1, wherein theindicia includes a graphical representation of the first lung nodule asthe targeted tissue and the second lung nodule as the non-targetedtissue.
 10. An apparatus for obtaining a tissue biopsy from a body, theapparatus comprising: a tube comprising one or more lumens extendingthrough the tube; a shaft positioned in a first lumen of the one or morelumens extending through the tube, wherein a distal end of the shaftincludes a tissue penetrating feature configured to penetrate tissuewhile extended out of the first lumen; and a transducer coupled to theshaft, the transducer being configured to: generate a first wave energyin response to a first transmission signal, receive a reflected portionof the first wave energy, wherein the reflected portion of the firstwave energy has a first magnitude value, generate a first signal of aplurality of second signals based on the first magnitude value, generatea second wave energy in response to a second transmission signal,receive a reflected portion of the second wave energy, wherein thereflected portion of the second wave energy has a second magnitudevalue, and generate a second signal of the plurality of second signalsbased on the second magnitude value, wherein one or more processors incommunication with the transducer are configured to: generate the firsttransmission signal, receive the first signal of the plurality of secondsignals, identify a first nodule based on the first signal of theplurality of second signals, generate the second transmission signal,receive the second signal of the plurality of second signals, identify asecond nodule based on the second signal of the plurality of secondsignals, compare a magnitude of the first signal of the plurality ofsecond signals to a magnitude of the second signal of the plurality ofsecond signals to identify the first nodule as a targeted tissue and thesecond nodule as a non-targeted tissue, and output indicia comprising agraphical representation that identifies the first nodule as thetargeted tissue and the second nodule as the non-targeted tissue. 11.The apparatus of claim 10, wherein the transducer is located within aninterior of the shaft.
 12. The apparatus of claim 11, wherein thetransducer includes an array of side-looking transducers, an array offorward-looking transducers, and an array of rearward-lookingtransducers.
 13. The apparatus of claim 12, wherein the array offorward-looking transducers is movable relative to the shaft.
 14. Theapparatus of claim 10, wherein the transducer includes at least onepiezoelectric ultrasound transducer, and the first and second signalsare electrical signals.
 15. The apparatus of claim 10, wherein the waveenergy is acoustic energy.
 16. The apparatus of claim 10, wherein thetransducer includes an array of forward-looking transducers.
 17. Theapparatus of claim 16, wherein the array of forward-looking transducersis movable relative to the shaft.
 18. The apparatus of claim 16, whereinthe transducer includes the array of forward-looking transducers and oneor more of an array of side looking transducers and an array ofrearward-looking transducers.